Quality control and non-clinical testing of iPSC- and ESC-derived medicinal products: A systematic review.

The lack of specific resources for quality control (QC) and non-clinical testing of cell-based medicinal products derived from embryonic and induced pluripotent stem cells (PSCs) contributes to uncertainty, variability, and delay in devising testing strategies. We conducted a systematic review on testing practices for diverse PSC-derived medicinal products using a custom-made ranking system, compiling a comprehensive "QC menu" of relevant critical quality attributes, established fit-for-purpose and promising techniques, and study designs for product development or clinical release. This consolidated resource could benefit product developers and regulators by creating informative testing strategies, ultimately increasing harmonization, facilitating clinical translation, and ensuring patient safety.